Amphotericin B Recalled for Potential Penicillin Cross Contamination
Attix Pharmaceuticals is recalling Amphotericin B active pharmaceutical ingredient due to potential cross contamination with penicillin during repackaging.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or high-risk scenarios like cross-contamination with a major allergen (penicillin) in a pharmaceutical context are rated as Severe (4), as Class I is reserved for reasonable probability of serious adverse health consequences or death.
Plain-English summary
Attix Pharmaceuticals is recalling all lots of Amphotericin B active pharmaceutical ingredient (API) that were repackaged and distributed between January 5, 2012, and February 12, 2015. The product is packaged in varying grams or kilograms in bags or drums. The total quantity involved is 5,500 grams.
The recall is being conducted because the API was repackaged in a facility that also handled penicillin products without adequate separation. This process created a potential for cross contamination with penicillin. The affected product was distributed nationwide to compounding pharmacies and research organizations.
Compounding pharmacies and research organizations that received this product should stop using it and contact the recalling firm for instructions on return or disposal. Consumers should not use this active pharmaceutical ingredient directly, as it is intended for professional use in the preparation of final drug products.
The recalled product
- Product
- Amphotericin B active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
- Manufacturer
- Attix Pharmaceuticals
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots repackaged and distributed between 01/05/12 to 02/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 470 recalled by Attix Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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